Megadyne Medical Products, Inc. recalls MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code…
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the…
Read the official notice →- Date
- 2023-08-09
- Country
- United States
- Brand
- Megadyne Medical Products
- Product
- MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225…
- Classification
- Class II
- Units
- Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of:…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Megadyne Medical Products recalls
- 2024-07-10
USMegadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return…
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
FDA · DeviceMegadyne Medical Products, Inc.Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN,…Official notice →- 2024-06-12
- US
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb),…
Reports of patient burns.
FDA · DeviceMegadyne Medical Products, Inc.Worldwide distribution. US nationwide including Puerto Rico; Australia,…Official notice → - 2024-01-03
- US
Megadyne Medical Products, Inc. recalls Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft…
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to…
FDA · DeviceMegadyne Medical Products, Inc.Worldwide distribution. US Nationwide including Puerto Rico; Argentina,…Official notice → - 2023-07-05
- US
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
Other drugs & medical recalls in the United States
- 2023-08-09
- US
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa…
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to…
FDA · DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONU.S. Nationwide distribution.Official notice → - US
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical…
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN,…Official notice → - US
Philips North America recalls Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud…
FDA · DevicePhilips North AmericaNationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan…Official notice → - US
Siemens Medical Solutions USA, Inc. recalls The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor…
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the…
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no…Official notice → - US
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96…
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with…
FDA · DeviceNeuMoDx Molecular IncUS Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New…Official notice → - US
Zimmer, Inc. recalls Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and…
Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
FDA · DeviceZimmer, Inc.AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea…Official notice →